Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)

Bradycardia, Atrial Tachyarrhythmia Clinical Trial

— MICRA  

Official title:

Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758210
• Other study ID #: IRB00084576
• Status: Completed
• Phase: N/A
• First received: April 19, 2016
• Last updated: October 9, 2017
• Start date: April 2016
• Est. completion date: October 24, 2016

Study information

• Verified date: October 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects that electromagnetic field exposure from using a tablet and smart phone have on a leadless pacemaker (MICRA device).

Description:

With advancement in technology, people are exposed to new sources of electromagnetic field like tablets and smart phones. There are magnets in smart phones and tablets that could affect the functions of pacemakers. The main purpose of this study is to evaluate the effects of electromagnetic field exposure from using a tablet and a smart phone with participants that have a leadless pacemaker (MICRA device) implanted inside them. Participants will be asked to report any symptoms that they experience during the testing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 24, 2016
• Est. primary completion date: October 24, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital

• Able to consent

Exclusion Criteria:

• Patients not enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital

• Children and vulnerable populations

Related Conditions & MeSH terms

• Bradycardia
• Bradycardia, Atrial Tachyarrhythmia
• Tachycardia

Intervention

Device:
• Use of a Tablet
Testing of the electromagnetic field exposure and it's affect on the participant's previously implanted MICRA device is assessed by interrogation of the device before using Tablet and while using the Tablet. The measured position of the Tablets tested will be normal routine position (noting at least 6 inches/15 centimeters from their pacemaker).
• Use of a Smart Phone
Testing of the electromagnetic field exposure and it's affect on the participant's previously implanted MICRA device is assessed by interrogation of the device before using a Smart phone and while using the Smart phone. The position of the Smart phone tested will be normal position at the ear and while texting (noting at least 6 inches/15 centimeters from their pacemaker).

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Response Assessed by Asynchronous Pacing When Using a Smart Phone	Cardiac pacing before and during use of a smart phone was monitored to assess asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.	Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Primary	Number of Participants Experiencing Asynchronous Pacing While Using a Tablet	Cardiac pacing before and during use of a tablet were monitored to assess if there is asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage.	Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Primary	Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone	Ventricular pacing before and during use of a smart phone was monitored to assess the presence of inhibition of ventricular pacing due to electromagnetic field exposure. The programmed pacing of the MICRA device is specific for each participant. The individualized, initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.	Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Primary	Device Response While Using a Tablet, Assessed by Ventricular Pacing	Ventricular pacing before and during use of a tablet was monitored to assess if there's inhibition of ventricular pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage. The assessment of this outcome measure takes an average of 5 minutes.	Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Secondary	Number of Participants Reporting Clinical Symptoms While Using a Smart Phone	Participants were asked to report any clinical symptoms that they experienced when using the smart phone.	Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Secondary	Number of Participants Reporting Clinical Symptoms While Using a Tablet	Participants were asked to report any clinical symptoms that they experienced when using the tablet.	Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)